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Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

NCT00254462 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2023-10-02

Study results available
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Summary

This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

Atomoxetine

Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.

DRUG

Placebo

Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.

BEHAVIORAL

Parent Training

All children will receive parent training for the duration of the study.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Christopher J Kratochvil, MD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-01
Primary Completion
2008-08-01
Completion
2008-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00254462 on ClinicalTrials.gov